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Vitamin D Supplementation in Children (MeltD)

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
cholecalciferol
Sponsored by
Children's Memorial Health Institute, Poland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitamin D Deficiency focused on measuring cholecalciferol, BMI, winter

Eligibility Criteria

4 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age 4-10 years; declaration of no use other preparations containing vitamin D; parental written informed consent

Exclusion Criteria:

  • Osteoporosis, autoimmunological disorders, sarcoidosis, exacerbation of asthma, hypercalcemia, nephrolithiasis, renal insufficiency, nephrotic syndrome, cholestasis, hepatitis, diabetes typ 1, anticonvulsant treatment, prolonged treatment with steroids, cimetidine, ketoconazole, teophiline, diuretics, anti-tuberculosis drugs, participation in another clinical trial

Sites / Locations

  • The Children's Memorial Health Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cholecalciferol

Arm Description

cholecalciferol at a dose 1000 IU /day for 3 months

Outcomes

Primary Outcome Measures

serum 25-hydroxyvitamin D level
after intervension vs baseline level

Secondary Outcome Measures

prevalence of vitamin D deficiency
serum 25-hydroxyvitamin D level < 20ng/ml (after intervension vs baseline)
prevalence of vitamin D suficiency
serum 25-hydroxyvitamin D level > 30ng/ml (after intervension vs baseline)

Full Information

First Posted
January 11, 2018
Last Updated
June 16, 2018
Sponsor
Children's Memorial Health Institute, Poland
Collaborators
Nutropharma Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03402698
Brief Title
Vitamin D Supplementation in Children
Acronym
MeltD
Official Title
Effectiveness of Vitamin D Supplementation in the Prevention of Vitamin D Deficiency in Children.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 9, 2018 (Actual)
Primary Completion Date
May 26, 2018 (Actual)
Study Completion Date
May 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Memorial Health Institute, Poland
Collaborators
Nutropharma Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Prevalence of vitamin D deficiency in children in the northern country during winter season is very high (up to 90%). Vitamin D supplementation at a dose 600 -1000 IU/d is recommended in Polish children from September till April. However, there is shortage of studies in Polish children. The aim of the study is to assess the effectiveness of vitamin D supplementation in the prevention of vitamin D deficiency in Polish children (4-10 years of age).
Detailed Description
Prevalence of vitamin D deficiency in children in the northern country during winter season is very high (up to 90%). Vitamin D supplementation at a dose 600 -1000 IU/d is recommended in Polish children from September till April. However, there is shortage of studies in Polish children. Aims: Assessment of the impact of vitamin D intake at a dose of 1000 IU / day on vitamin D status in children aged 4-10 years. Evaluation of the effectiveness of supply of vitamin D at a dose of 1000 IU / day in preventing vitamin D deficiency and maintaining optimal vitamin D status ( 25OHD level >30ng/ml) Evaluation of vitamin D status depending on age, BMI and body composition. Assessing the safety and tolerability of mel ● tiki vitamin D in children. Material: Children aged 4-10 years Study desing: Prospective intervention trial Intervention: cholecalciferol at a dose 1000 IU/day for 3 months Methods: Analysis of clinical characteristics (attendance at kindergarten / school, consumption of products rich in vitamin D, exposure to sun, use of sunblock's, the overall child's health (chronic diseases, medications, vitamins, micronutrients) Anthropometric measurements (body weight, height, BMI, assessment of body fat content - body composition by bioimpedance method- TANITA) Assessment of vitamin D status (serum total 25OHD concentration in blood serum by immunochemiluminescence method) Collecting data on the tolerability and safety of meliki ● tiki vitamin D including possible symptoms of vitamin D overdose

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency
Keywords
cholecalciferol, BMI, winter

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cholecalciferol
Arm Type
Experimental
Arm Description
cholecalciferol at a dose 1000 IU /day for 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
cholecalciferol
Intervention Description
supplementation at a dose 1000 IU/d
Primary Outcome Measure Information:
Title
serum 25-hydroxyvitamin D level
Description
after intervension vs baseline level
Time Frame
during 3 months of vitamin D supplementation
Secondary Outcome Measure Information:
Title
prevalence of vitamin D deficiency
Description
serum 25-hydroxyvitamin D level < 20ng/ml (after intervension vs baseline)
Time Frame
during 3 months of vitamin D supplementation
Title
prevalence of vitamin D suficiency
Description
serum 25-hydroxyvitamin D level > 30ng/ml (after intervension vs baseline)
Time Frame
during 3 months of vitamin D supplementation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 4-10 years; declaration of no use other preparations containing vitamin D; parental written informed consent Exclusion Criteria: Osteoporosis, autoimmunological disorders, sarcoidosis, exacerbation of asthma, hypercalcemia, nephrolithiasis, renal insufficiency, nephrotic syndrome, cholestasis, hepatitis, diabetes typ 1, anticonvulsant treatment, prolonged treatment with steroids, cimetidine, ketoconazole, teophiline, diuretics, anti-tuberculosis drugs, participation in another clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justyna Czech-Kowalska
Organizational Affiliation
The Children's Memorial Health Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Memorial Health Institute
City
Warsaw
ZIP/Postal Code
04-730
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

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Vitamin D Supplementation in Children

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